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The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passeo 18 PTA | Previous treatment with uncoated Passeo 18 PTA balloon catheter |
| |
| Passeo-18 Lux DCB | Previous teatment with Passeo-18 Lux DCB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passeo-18 | Device | POBA |
| |
| Passeo-18 Lux |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival at five years after index procedure, defined as death from any cause | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, defined as the time in days after index procedure to date of death from any cause. | 60 months | |
| Major amputations of target extremities | 60 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from previous studies.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Zeller, Prof Dr | Clinic of Cardiology and Angiology II Bad Krozingen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Univ.-Klinikum Graz, Ambulanz für Angiologie | Graz | Austria | ||||
| Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie |
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| Device |
DCB |
|
| Clinically-driven target lesion revascularization |
| 60 months |
| Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II. | 60 months |
| Vienna |
| Austria |
| Vascular Research Center Bornheiden, Imelda Hospital | Bonheiden | Belgium |
| A.Z. Sint-Blasius | Dendermonde | Belgium |
| Clinic of Cardiology and Angiology II Bad Krozingen | Bad Krozingen | Germany |
| Gefäßzentrum am KEH | Berlin | Germany |
| University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie) | Leipzig | Germany |
| Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum | Rosenheim | Germany |